UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000045648 |
|---|---|
| Receipt number | R000052016 |
| Scientific Title | A Study of the effects of a test-food on gut microenvironment |
| Date of disclosure of the study information | 2022/10/07 |
| Last modified on | 2022/10/07 11:55:41 |
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Basic information
Public title
A Study of the effects of a test-food on gut microenvironment
Acronym
A Study of the effects of a test-food on gut microenvironment
Scientific Title
A Study of the effects of a test-food on gut microenvironment
Scientific Title:Acronym
A Study of the effects of a test-food on gut microenvironment
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to validate some kind of effect by the test-food intakes for two weeks on gut microenvironment and immunity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal flora (next generation-targeted amplicon sequencing analysis)
Key secondary outcomes
1. Defecation status (the number of days, frequency, quantity, property, color, fecal odor, feeling of incomplete evacuation, abdominal pain)
2. In stool: short chain fatty acids, ammonia, spoiled products, pH, water, and IgA
3. In blood: NK-cell activity, highly sensitive CRP, IL-6, and TNF-alpha
4. In saliva: cortisol and alpha-amylase
5. Constipation assessment scale-mid term
6. MOS 36-Item Short-Form Health Survey version2 (acute version)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food (10 capsules a day) with water/lukewarm water to the subjects for 2 weeks.
Interventions/Control_2
Ingestion of the placebo food (10 capsules a day) with water/lukewarm water to the subjects for 2 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects ranging in age from 20 to 64, at informed consent.
(2) Subjects ranging in defection frequency from not less than three times to less than five times a week.
(3) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who take steadily (not less than three times a week) in the health-specific/functional/supplementary/health foods, yogurts or lactic acid beverages, which might affect the test results (intestinal regulation and immune maintenance).
(2) Subjects who have taken affecting medicines (allergic/gut/laxative/antibiotic regulation) except eye/nose drops, within the last month before the hospital visiting (0 W at the first stage).
(3) Subjects who will vaccinate within the last three weeks before the hospital visiting (0 W at the first stage) and during this study.
(4) Subjects who had undergone appendectomy.
(5) Subjects who have received the affecting surgery (e.g. colonoscopy, removal of gallstones and/or gall bladder, or gastric bypass surgery) within half a year before obtaining the consent.
(6) Subjects who will change their life style and dietary habit during this study.
(7) Subjects with extremely irregular dietary habits.
(8) Subjects who take excessive alcohol.
(9) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(10) Pregnant, possibly pregnant, or lactating women.
(11) Subjects having drug and/or food allergy.
(12) Subjects who are now under another clinical test with some kind of medicine and/or health food, or took part in that within four weeks before this study, or will participate in that after giving informed consent to take part in this study.
Subjects - -
(13) who donated their blood components or blood (0.2 L) within the last month,
(14) who donated his blood (0.4 L) within the last 3 months,
(15) who donated her blood (0.4 L) within the last 4 months,
(16) being collected in total of his blood (1.2 L) within the last 12 months and in this study,
(17) being collected in total of her blood (0.8 L) within the last 12 months and in this study - - .
(18) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052016
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| Research case data specifications | |
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| Registered date | File name |
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